Surfacer System to Facilitate Access in Venous Occlusions (SAVE)

Prospective, single-arm, multicentre, international Registry of the Surfacer System for the treatment of patients with limited or diminishing upper body venous access or pathology impeding standard access methods.The purpose of this post-market Registry is to assess the standard of care and clinical outcomes of the Surfacer System used in clinical routine according to the approved commercial indications.

Study Overview

• Status: Completed
• Conditions: Chronic Venous Thrombosis; Venous Thrombosis Upper Extremity; Venous Thrombosis Upper Extremity Superficial Veins

Detailed Description

This is a prospective, single-arm, multicenter registry of the Surfacer System for patients with limited or diminishing upper body venous access or pathology impeding standard access methods. The need for long term access and lack of availability of veins has led to the development of the Surfacer System, which facilitates reliable and repeatable placement of central venous catheters and restores central venous access. Based on European legislation, this Registry is considered to be an observational study. No additional diagnostic or monitoring procedures as a result of the inclusion are applied to the patients. Available data will be collected in a protected database. Up to 30 patients will be enrolled in 5 sites in Europe. Patients requiring central venous access will be enrolled who meet inclusion and exclusion criteria and for whom the device is indicated.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Austria
  • Waehringer Guertel 18-20
    • Vienna, Waehringer Guertel 18-20, Austria, A 1090
      • University of Vienna
• Germany
  • Cologne, Germany, D-50937
    • University Hospital of Cologne
  • Dusseldorf, Germany, 40549
    • Schon Klinik
• Italy
  • Milan, Italy, 20153
    • Azienda Ospedaliera San Carlo Borromeo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients requiring central venous access for:

• dialysis
• chemotherapy nutrition
• delivery of any pharmacological therapy

Description

Inclusion Criteria: patients referred for placement of a central venous catheter

• patients with limited or diminishing upper body venous access
• pathology impeding standard access methods
• signed informed consent

Exclusion Criteria:

• vulnerable subjects or incapable of giving consent
• contraindications to central venous access based on treating physicians opinion or standard of care
• occlusion of the right femoral vein
• occlusion of the iliac vein
• occlusion of the inferior vena
• acute thrombosis within a vessel (IVC, brachiocephalic and subclavian)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of all acute safety and device related serious adverse event recorded on case report forms	overall complication rate compared to safety data	Procedure through discharge at 24 hours post procedure. Data will be presented through study completion, 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to place central venous access catheter using Surfacer system	performance evaluated by procedure time measured by time to create access	Procedure
Surfacer system advancement of the exit wire outside the vein	Ability to advance system from femoral vein to supraclavicular exit as measured by time	procedure
Insertion of a standard central venous access catheter to deliver fluid or pharmacological agents	introducing a standard central venous access catheter over the needle wire	procedure

Collaborators and Investigators

• Sponsor: Merit Medical Systems, Inc.
• Investigators: Study Director: Laura Minarsch, RT, Bluegrass Vascular

Publications and helpful links

General Publications

• Frykholm P, Pikwer A, Hammarskjold F, Larsson AT, Lindgren S, Lindwall R, Taxbro K, Oberg F, Acosta S, Akeson J. Clinical guidelines on central venous catheterisation. Swedish Society of Anaesthesiology and Intensive Care Medicine. Acta Anaesthesiol Scand. 2014 May;58(5):508-24. doi: 10.1111/aas.12295. Epub 2014 Mar 5.
• Elayi CS, Allen CL, Leung S, Lusher S, Morales GX, Wiisanen M, Aikat S, Kakavand B, Shah JS, Moliterno DJ, Gurley JC. Inside-out access: a new method of lead placement for patients with central venous occlusions. Heart Rhythm. 2011 Jun;8(6):851-7. doi: 10.1016/j.hrthm.2011.01.024. Epub 2011 Jan 13.
• Baskin JL, Pui CH, Reiss U, Wilimas JA, Metzger ML, Ribeiro RC, Howard SC. Management of occlusion and thrombosis associated with long-term indwelling central venous catheters. Lancet. 2009 Jul 11;374(9684):159-69. doi: 10.1016/S0140-6736(09)60220-8.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): September 20, 2018
• Study Completion (Actual): October 4, 2018

Study Registration Dates

• First Submitted: August 12, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimated): August 23, 2016

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: CP0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED